Teams at Fortrea

Oversee clinical trial start-up and delivery from site identification through database lock. Manage timelines, budgets, risks, regulatory and ethics submissions, site selection, contracts, supplies, recruitment, monitoring, quality, documentation, and site payments. Lead client communications and collaborate with global cross-functional teams to ensure compliance, patient safety, data integrity, inspection readiness, and successful trial execution.

Coordinates clinical study site start-up and maintenance activities, including collecting and reviewing essential documents, preparing regulatory and IRB/IEC submissions, tracking approvals, updating electronic systems, and ensuring compliance with ICH/GCP, regulations, SOPs, timelines, and quality standards. Acts as a primary contact for investigative sites and regulatory bodies, supports informed consent customization, contract and budget tracking, risk escalation, and site activation strategy. May mentor less-experienced colleagues and requires frequent domestic and international travel.

Conducts Phase I clinical trial site monitoring and management, including pre-study, initiation, routine monitoring, and close-out visits. Ensures protocol compliance, informed consent, participant safety, data integrity, and regulatory adherence. Performs CRF review, query resolution, registry management, feasibility work, and Serious Adverse Event reporting. Coordinates assigned clinical projects, liaises with vendors and clients, supports study staff training, and travels approximately 40–50% overnight to domestic and occasional international sites.